Kahn J, Kaplan L, Gambertoglio J, Arri C, Williams R, Lifson J, Volberding P; International Conference on AIDS.
Int Conf AIDS. 1990 Jun 20-23; 6: 202 (abstract no. S.B.465).
Division of AIDS Activities, Department of Medicine, San Francisco General Hospital, San Francisco, CA, USA
OBJECTIVE: To evaluate the safety and pharmacokinetics of GLQ223(TM), a plant protein derived from root tubers of Trichosanthes kirilowii in subjects with AIDS and ARC. METHODS: Phase 1 trial with dose escalation at a University-affiliated hospital AIDS clinic. 18 subjects were enrolled. GLQ223(TM) was administered by rapid intravenous infusion on day 1 at doses of 1, 8, 16, 24 and 36 mug/kg. All subjects were monitored for tolerance and toxicity. Immunologic and virologic values were followed. RESULTS: GLQ223(TM) administration was not associated with significant toxicity as determined by serum chemistry, hematologic or immunologic parameters. One subject experienced a significant neurologic toxicity, that resembled an acute disseminated encephalomyelitis. No consistent or sustained changes in CD4 lymphocyte populations or HIV antigen levels were observed. The volume of distribution of GLQ223(TM) is small and clearance remains constant over the dose range studied. CONCLUSIONS: Subjects administered single doses of GLQ223(TM) at the levels used in this study had a variety of clinically important side effects and one life threatening neurologic toxicity. Peak serum concentrations of GLQ223TM were transiently comparable to concentrations shown to have in vitro anti-viral activity. GLQ223(TM) serum concentrations were not of sufficient duration to approach effective in vitro activity. No clinical efficacy was demonstrated in this single bolus dose study. GLQ223(TM) is not currently an alternative to approved anti-retroviral medications and greater understanding of the pharmacokinetic and pharmacodynamic properties of GLQ223(TM) are required.
Publication Types:
Keywords:
- AIDS-Related Complex
- Acquired Immunodeficiency Syndrome
- CD4-Positive T-Lymphocytes
- Clinical Trials as Topic
- Clinical Trials, Phase I as Topic
- Drug Tolerance
- HIV Antigens
- In Vitro
- Infusions, Intravenous
- Meditation
- Plant Proteins
- Time
- Trichosanthin
- immunology
Other ID:
UI: 102196279
From Meeting Abstracts